BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 17481130 · Received August 8, 2023

    Report

    Report Number
    2249723-2023-03582
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    August 1, 2023
    Report Date
    May 2, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9 (DEVICE AVAILABLE FOR EVAL, RETURN TO MANUFACTURE DATE), G3, G6, H2, H3, H4, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODE, INVESTIGATION CONCLUSION), H10. ADDITIONAL INFORMATION: E1(EVENT SITE TELEPHONE:(B)(6). IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A ISSUE OF CONSTANTLY ALARMING. THE PATIENT INVOLVEMENT IS UNKNOWN. A GETINGE FIELD SERVICE ENGINEER EVALUATED THE UNIT AND DONE VISUAL INSPECTION EXTERNALLY ALL CHECKED OK. NOT ABLE TO REPRODUCE " CONSTANT ALARM". ABLE TO OBSERVE IN LOGS TE 128, AND 139.REPLACED POWER MANAGEMENT BOARD(D670-00-1162).FULL CALIBRATION, FUNCTIONAL TESTING AND SAFETY CHECK TO FACTORY SPECIFICATIONS. RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. PLEASE REFER TO THE ROOT CAUSE EVALUATION FIELD FOR DETAILS. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0670-00-1162 REV. H, 21 00101 02_EDM, WITH A REPORTED UNIT FAILURE OF CONSTANT ALARMS. ERROR CODES 128 AND 139. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED THE BOARD INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE BOARD TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION E AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. TESTED FOR 1 HOUR WITH NO ISSUES OR ERROR CODES. FAT COULD NOT VERIFY THE REPORTED PROBLEM. SENDING THE BOARD TO THE SUPPLIER FOR FAILURE ANALYSIS PER PROCEDURE NUMBER 0002-07-D008 REV. AP. FAT RECEIVED PART NUMBER 0670-00-1162 BACK FROM THE SUPPLIER. THE SUPPLIER TESTED THE BOARD AND NO ABNORMALITIES WERE FOUND. PLEASE SEE ATTACHMENTS FOR FAILURE ANALYSIS PAPERWORK. THIS INVESTIGATION IS NOW COMPLETE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AQ. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS CONSTANTLY ALARMING AND NOT DISPLAYING ANY ERROR. THE ONLY WAY TO STOP FROM ALARMING IS TO PULL THE BATTERIES. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2317924 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.